MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.Requested patient demographics however not provided.

Event Description

It was reported that after an entyvio (280ml) infusion, the user disconnect the iv and flushed the line with normal saline.Prior to removing the patient¿s iv, the user noticed fluid on the tray of the arm chair although the iv, patient arm and the pillow were completely dry.The user then flushed the line and noticed a leak above the y-site from a pin hole in the tubing.The patient¿s arm and pillow were just positioned enough that the infusion dripped right into the tray and did not come into contact anywhere else.The patient could not wait for a response from the doctor and left the clinic due to a previous engagement.The user notified the dr.No additional infusion required and to continue with entyvio treatment as usual.There was no report of patient harm.An incomplete date of (b)(6) 2019 provided.

Event Description

It was reported that 30min.After an entyvio (560ml) infusion completed, the clinician disconnected the iv and flushed the line with normal saline.Prior to removing the patient¿s iv, the nurse noticed fluid on the tray of the arm chair, however the iv, patient's arm and the pillow were completely dry.The nurse then flushed the line and noticed a leak above the y-site from a pin hole in the tubing.The infusion had dripped into the tray and did not come into contact anywhere else.The patient could not wait for a response from the doctor and left the clinic due to a previous engagement.The nurse notified the doctor; no additional infusion was required and the patient was instructed to continue with entyvio treatment every 8 weeks.One week later, the patient experienced unspecified symptoms requiring an extra entyvio infusion.An incomplete date of (b)(6) 2019 was provided.

Manufacturer Narrative

No product will be returned per customer.The customer¿s complaint could not be confirmed because the product was not sequestered and will not be returned for failure investigation.The root cause of this failure was not identified.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8458261
• MDR Text Key: 140145775
• Report Number: 9616066-2019-00857
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2021
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 18093086
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYRINGE, THERAPY DATE UNK.
• Patient Outcome(s): Required Intervention